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Human Subjects Division (HSD)

Announcements

Expansion of Minimal Risk Category 5

Nov 3, 2009 at 8:38am

Background.  To qualify for "Minimal Risk" review, research must involve no more than minimal risk and it must fit into one of nine categories described by federal human subjects regulations. 

Category #5 refers to research involving the use of individually-identifiable materials (data, documents, records, or specimens) that are not collected specifically for the researcher's proposed project.  Until now, this category has been restricted to research involving the use of materials that were originally (or will be) collected for non-research purposes.   Example:   the research use of "left over" specimens from clinical procedures.

Revised policy.  The University of Washington IRB is acting upon a recently published statement from a federal regulatory agency that clarifies the agency's intent for this Category to include existing individually-identifiable materials collected for some other research purpose.  Example:  a researcher's use of residual blood samples already obtained by another researcher as part of a different research study.   The table below depicts this revised policy. 

This policy is effective immediately.  It means that many research studies will now qualify for Minimal Risk review instead of being reviewed by a full IRB committee.

 

The materials exist prior to the date when the researcher submits his/her IRB application

Some/all of the materials will be collected after the researcher submits his/her IRB application

Materials originally collected for non-research purpose

 

May qualify for Category 5

 

 

May qualify for Category 5

Materials originally collected for some other research purpose

 

(New)  May qualify for Category 5

 

 

Does not qualify for Category 5